This 6 arm study will evaluate the efficacy, safety and pharmacokinetics of 5 doses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Patients will be randomized to one of 6 groups to receive RO4998452 at doses of 2.5mg, 5mg, 10mg, 20mg or 40mg po daily, or placebo daily. Patients pre-treated with stable metformin will continue to take their usual dose of metformin throughout the study.The anticipated time on study treatment is \<=3 months
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
394
Absolute Change in HbA1c
Time frame: Baseline, Week 4, Week 8 and Week 12
Change From Baseline in Fasting Plasma Glucose (mmol/L)
Time frame: Baseline and Week 12
Change From Baseline in Mean Daily Glucose Concentration (mmol/L)
Time frame: Baseline and Week 12
Change From Baseline in Fructosamine Concentration (μmol/L)
Time frame: Baseline and 12 weeks
Change From Baseline in Meal Tolerance Test: 0-3h Mean Glucose Concentration (mmol/L)
Time frame: Baseline and Week 12
Change From Baseline in Meal Tolerance Test: 0-3h Mean Insulin Concentration (mmol/L)
Time frame: Baseline and Week 12
Change From Baseline in Meal Tolerance Test: 0-3h Urinary Glucose Excretion (mmol/L)
Time frame: Baseline and Week 12
Change From Baseline in Body Weight (kg)
Time frame: Baseline and Week 12
Percentage of Participants Treated to Target HbA1c < 7%
Time frame: Baseline up to 12 weeks
Percentage of Participants Treated to Target HbA1c < 6.5%
Time frame: Baseline up to 12 weeks
Percentage of Participants With at Least One Adverse Event
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10mg po daily for 12 weeks
20mg po daily for 12 weeks
40mg po daily for 12 weeks
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Palm Springs, California, United States
Unnamed facility
Bradenton, Florida, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Hayden Lake, Idaho, United States
Unnamed facility
Rochester, New York, United States
Unnamed facility
Greensboro, North Carolina, United States
Unnamed facility
Midland, Texas, United States
...and 57 more locations
Time frame: Baseline up to 12 weeks